LSPediA Completes the FDA DSCSA Pilot Program Project

LSPediA today announced the company has successfully completed the FDA DSCSA Pilot Program Project for Router Service Solution for Verification/Notification and Interoperability 2023. Working with companies composed of between 200 to 20,000 employees, the pilot focused on end-to-end supply chain activities using the unique product identifier to perform verifications and interoperability.

The pilot achieved several firsts in the industry:

1. The most live serialized Rx packages verified – Over 20,000 packages are scanned and verified end to end in the supply chain by the unique Product Identifier.
2. The most functional groups participated – Over 11 functional groups worked activities related to managing the serialized Rx. They represent production, warehouse, supply chain, quality, compliance, IT, customer service, accounting, pharmacy operations, corporate security, and reverse logistics.
3. The most complete serialized supply chain demonstration with live inventory – Participants saw products moved end to end and learned the functions and usage of unique a Product Identifier beyond their four walls.
4. The most complete verification scenarios – The pilot performed 10 verification scenarios covering returns, positive, negative, recall, suspect, counterfeit, illegitimate, theft, fraud, and phishing.

The pilot participating companies who represented the end-to-end Rx supply chain are manufacturer, wholesaler, and dispenser partners.

• LSPediA Inc.
• Kowa Pharmaceuticals America, Inc.
• Ingenus Pharmaceuticals, LLC
• Auburn Pharmaceutical Co.
• AmerisourceBergen Corp.
• Smith Drug Co.
• SpartanNash Co.

Working in concert, the participants successfully executed planned activities and achieved the goals and objectives as designed. A final report was submitted to the FDA and is available to download by request through LSPediA. The report provides a wealth of data, KPIs, and other information, summarized here:

LSPediA FDA DSCSA Pilot Program Summary

“First and foremost, we extend our appreciation to all of the participants,” said Riya Cao, LSPediA CEO. “Thanks to everyone who dedicated time and resources to create an environment that mimicked a production-like transaction pool of data and activity.”

The Pilot Project’s important findings and achievements include:

• Testing the state-of-the-art OneScan software, including its Investigator module, which enables a collaborative and automated single-source-of-truth platform for product investigations
• An industry recommendation concerning undesirable labeling practices encountered in the product verification process
• Discovering that, based on warehouse inventory scans, a large number of “good” products are still failing verification due to barcode anomalies
• A readiness issue discovered during negative verification “fire drills,” which revealed SOP gaps including serialization and documentation, audit trails, etc.
• Products associated with manufacturers not using OneScan failed to return a verification response due to their solution providers not being enabled or in production

The FDA will now spend time absorbing the comprehensive reporting and likely issue a report containing insights and industry guidance. For complete Pilot Program details, contact LSPediA.

About LSPediA – Life Sciences Solutions

LSPediA provides SaaS solutions to the pharmaceutical industry. Manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to make, move, track, verify, and protect the drug products in their care for patient safety.

LSPediA is different because our solution potential is limitless. Built with user efficiency, automation, and data security at their core, our solutions are transforming compliance and supply chain efforts. LSPediA’s OneScan, RxChain, and Investigator technologies enable error-free and keyboard-free capabilities for ASN, EPCIS, VRS, issue tracking, and interoperability.

For more information about our capabilities, call +1 (248) 973-2008, email info@lspedia.com, or visit our website at www.lspedia.com.